Trevi Therapeutics(TRVI) - 2020 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q3 2020, the company reported a net loss of $7.4 million, unchanged from the same quarter in 2019 [21] - R&D expenses decreased to $4.8 million from $5.7 million in Q3 2019, primarily due to reduced activity in the Phase 2 trial for chronic cough due to COVID-19 [22] - G&A expenses increased to $2.4 million from $2 million in Q3 2019, attributed to higher stock-based compensation and consulting fees [22] - Cash and cash equivalents totaled $53.3 million as of September 30, 2020, down from $57.3 million at the end of 2019 [23] Business Line Data and Key Metrics Changes - The company is focused on developing Haduvio for severe pruritus in prurigo nodularis, with approximately 250,000 patients in the U.S. and 430,000 globally [8] - The PRISM trial for prurigo nodularis has randomized approximately 190 subjects, with over 95% opting to continue into the open-label extension [11][46] - The Phase 2 trial for chronic cough in idiopathic pulmonary fibrosis (IPF) was paused due to COVID-19 but has resumed with an amended protocol [18] Market Data and Key Metrics Changes - The company is conducting trials in both the U.S. and Europe, with over 60 sites activated for the PRISM trial [9] - The company is exploring potential study sites in Germany to enhance enrollment for the IPF cough study [19] Company Strategy and Development Direction - The company aims to complete enrollment in the PRISM trial by Q3 2021 and report top-line data in Q4 2021 [15] - The focus remains on optimizing development execution and resource allocation for both pruritus and cough programs [20] - The company is considering starting a second trial for prurigo nodularis before receiving results from the first trial, depending on resource availability [56] Management's Comments on Operating Environment and Future Outlook - Management noted that enrollment for the PRISM trial has been strong post-COVID, with a good pace of recruitment [28] - The company is optimistic about the competitive landscape, particularly in the IPF cough space, following the failure of a competitor's drug [33] - Management expressed confidence in the ability to adapt to ongoing COVID-19 challenges while maintaining trial progress [60] Other Important Information - The company has implemented funding strategies, including a $14 million term loan and $2.5 million from common stock sales, to extend its cash runway into the first half of 2022 [24] Q&A Session Summary Question: Enrollment progress for PRISM trial - Management indicated that enrollment has been strong, averaging 15 to 20 patients per month, with a target of 360 total participants [28] Question: Chronic cough trial details - The target for the chronic cough trial has been increased to 60 patients, with the same number of completers expected [30] Question: Dropout rates and adverse events - Dropout rates are within expected ranges, and adverse events reported are typical, including dizziness and nausea [38] Question: Moving forward with IPF cough program - Management stated that resources are adequate to support both trials, with a focus on recruitment and enrollment [40] Question: Starting a second trial for PN - Management is considering starting a second trial in parallel but prefers to wait for data from the first trial to optimize the protocol [56] Question: Competitive landscape and comfort level - Management expressed confidence in their competitive position, particularly against a competitor that recently failed in the cough space [57] Question: Impact of lockdowns on enrollment - Current lockdown procedures do not restrict patient visits as previously, allowing for continued enrollment [60]